NCT05122624: PredicTB

A Clinical Risk Score for Early Management of TB in Uganda

Completed NA Results posted Last updated 23 July 2024

What this trial tests

NA trial testing PredicTB score in Tuberculosis, Pulmonary in 3,332 participants. Completed in 29 February 2024.

Timeline

10 November 2021

Primary endpoint
15 July 2023

29 February 2024

Quick facts

Lead sponsor	Johns Hopkins Bloomberg School of Public Health
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	diagnostic
Enrollment	3,332
Start date	10 November 2021
Primary completion	15 July 2023
Estimated completion	29 February 2024
Sites	1 location across Uganda

Drugs / interventions tested

• PredicTB score

Conditions studied

• Tuberculosis, Pulmonary — all drugs for Tuberculosis, Pulmonary →

Sponsor

Johns Hopkins Bloomberg School of Public Health

Who can join

15 and older, any sex, with Tuberculosis, Pulmonary. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Difference in 7-day Treatment Initiation From Pre-implementation to Post-implementation Primary · Up to 12 months post intervention

The percentage of participants with microbiologically confirmed TB who initiated treatment within 7 days during post-implementation 'minus' The percentage of participants with microbiologically confirmed TB who initiated treatment within 7 days during pre-implementation

Group	Value	95% CI
Score Intervention Arm	1	-6 – 8
Control Arm	-13	-22 – -5

Implementation: Percentage of Encountered Patients at Intervention Arm Who Initiated the Same-day Treatment Based on PredicTB Score as Indicated Primary · Up to 12 months

Percentage of patients who initiated same-day treatment divided by the number of patients who had a higher PredicTB score than the clinic-specific score of treatment threshold in the post-implementation period in intervention arm

Group	Value	95% CI
Score Intervention Arm	46

Difference in TB Mortality From Pre-implementation to Post-implementation Secondary · 12 Months

The percentage of participants with microbiologically confirmed TB who died of any cause in the post-implementation "minus" The percentage of participants with microbiologically confirmed TB who died of any cause in the pre-implementation

Group	Value	95% CI
Score Intervention Arm	-1	-4 – 1
Control Arm	-1	-6 – 5

Difference in Loss to Care From Pre-implementation To Post-implementation Secondary · 12 Months

The percentage of participants with microbiologically confirmed TB who were lost to follow-up in the post-implementation "minus" The percentage of participants with microbiologically confirmed TB who were lost to follow-up in the pre-implementation

Group	Value	95% CI
Score Intervention Arm	1	-3 – 2
Control Arm	1	-5 – 3

Difference in Percentage of Participants With Microbiologically Confirmed TB Secondary · Up to 12 months post-implementation

Difference in the percentage of participants with microbiologically confirmed TB who initiated treatment within 7 days from post-implementation to pre-implementation at intervention arm "minus" Difference in the percentage of participants with microbiologically confirmed TB who initiated treatment within 7 days from post-implementation to pre-implementation at comparison arm

Group	Value	95% CI
Score Intervention Arm	14	10 – 19
Control Arm	0	0 – 0

Reach: Percentage of Patients Who Were Administered (or Evaluated) by PredicTB Score Secondary · Up to 12 months

Percentage of patients who were administered (or evaluated) by PredicTB score among those who presented presumptive TB symptoms at clinics in the post-implementation period in intervention arm

Group	Value	95% CI
Score Intervention Arm	66

Adoption: Percentage of Providers Adopting PredicTB Secondary · Month 18

Percentage of providers using PredicTB in over 50% of encounters in which sputum is submitted for pulmonary TB diagnosis among those seeing \>5 patients who submit sputum for diagnosis of pulmonary TB

Group	Value	95% CI
Score Intervention Arm	100

Maintenance: Change in Effectiveness Over Time in the Post-implementation Phase at Intervention Arm Secondary · Up to 12 months

Percentage of participants with microbiologically confirmed TB who initiated treatment within seven days in the post-implementation phase at intervention arm "minus" Percentage of participants with microbiologically confirmed TB who initiated treatment within seven days in the post-implementation phase at intervention arm

Group	Value	95% CI
Score Intervention Arm	-16	-31 – 1

Sponsor's own description

Although curative treatment exists, tuberculosis (TB) remains the leading cause of infectious mortality worldwide - often because people seek care for TB symptoms in highly resource-constrained clinics that cannot provide same-day diagnostic testing. The research team has developed an easy-to-use clinical risk score that, if implemented in these settings, might help clinicians identify patients at high risk for TB and thereby start treatment for those patients on the same day. This study will investigate the effectiveness and implementation of this score in four peri-urban clinics in Uganda, providing critical pragmatic data to inform (or halt) the design of a definitive large-scale cluster randomized trial.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Effectiveness and Implementation of a Clinical Risk Score for Early Diagnosis of Tuberculosis in Uganda: A Pragmatic, Clustered Randomization Clinical Trial.
   Baik Y, Musoke M, Twinamasiko A, Lamunu M, et al · · 2025 · PMID 40587503 · DOI 10.1513/annalsats.202404-422oc